Back to resultsPredictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes , Sohag Experience.
Primary Purpose
Chronic Calculous Cholecystitis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Calculous Cholecystitis
Eligibility Criteria
Inclusion Criteria: patients with symptomatic gall stones Exclusion Criteria: lap to open conversion due to equipment failure pregnancy common bile duct stone obstructive jaundice unfit for general anesthesia patients refusing lap cholecystectomy.
Sites / Locations
- Sohag University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Easy cholecystectomy
moderate severe cholecystectomy
difficult cholecystectomy
Arm Description
easy procedure with no complications
moderate severity with prolonged time or complication .
very prolonged time , complication or conversion to open cholecystectomy .
Outcomes
Primary Outcome Measures
Validation and applicability of scoring systems
the scoring system should reach high percentage to be applicable and could be used for scoring difficulty.A comparison between preoperative score and intraoperative score, then the success of a scoring system is by the high percentage sensitivity ,preoperative data sheet will be taken from all patients ,then the first look intraoperative will judge the score through multiple items , the cross matching will be done between the two scores. and to measure the results,There are many scoring system for example Randawa preoperative and intraoperative score , Nassar preoperative and intraoperative score ,matching the result of both preoperative and intraoperative will be done to validate each one. Randawa score classified into easy and moderate and severe difficulty based on time lapsed during cholycystectomy ,intraoperative problems and complications Nassar uses the intraoperative shape of gall bladder to classify the difficulty from 1 to 5 grades upon the first look to the gall bladder.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05859607
Brief Title
Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes , Sohag Experience.
Official Title
Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes, Sohag Experience.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
October 18, 2023 (Anticipated)
Study Completion Date
October 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
laparoscopic cholecystectomy nowadays is the most common surgery done by General surgery surgeons , so it is necessary to evaluate the difficulty of each case prior to surgery and from the first look ,to avoid complications and improve outcomes , so scoring systems are needed for better assessment of the overall condition and make good decision .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Calculous Cholecystitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Easy cholecystectomy
Arm Type
Active Comparator
Arm Description
easy procedure with no complications
Arm Title
moderate severe cholecystectomy
Arm Type
Active Comparator
Arm Description
moderate severity with prolonged time or complication .
Arm Title
difficult cholecystectomy
Arm Type
Active Comparator
Arm Description
very prolonged time , complication or conversion to open cholecystectomy .
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy
Intervention Description
conventional laparoscopic cholecystectomy with calculation of difficulty scorings
Primary Outcome Measure Information:
Title
Validation and applicability of scoring systems
Description
the scoring system should reach high percentage to be applicable and could be used for scoring difficulty.A comparison between preoperative score and intraoperative score, then the success of a scoring system is by the high percentage sensitivity ,preoperative data sheet will be taken from all patients ,then the first look intraoperative will judge the score through multiple items , the cross matching will be done between the two scores. and to measure the results,There are many scoring system for example Randawa preoperative and intraoperative score , Nassar preoperative and intraoperative score ,matching the result of both preoperative and intraoperative will be done to validate each one. Randawa score classified into easy and moderate and severe difficulty based on time lapsed during cholycystectomy ,intraoperative problems and complications Nassar uses the intraoperative shape of gall bladder to classify the difficulty from 1 to 5 grades upon the first look to the gall bladder.
Time Frame
6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with symptomatic gall stones
Exclusion Criteria:
lap to open conversion due to equipment failure pregnancy common bile duct stone obstructive jaundice unfit for general anesthesia patients refusing lap cholecystectomy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud F Mahmoud, resident
Phone
01159771450
Email
mahmoudfahmy@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa A Radwan, professor
Phone
01001988455
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy m Amin, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes , Sohag Experience.
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